[Federal Register: November 26, 2004 (Volume 69, Number 227)]
[Notices]
[Page 68931-68935]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26no04-80]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2202-FN]
Medicare and Medicaid Programs; Approval of Application for
Deeming Authority for Ambulatory Surgical Centers by the American
Association for Accreditation of Ambulatory Surgery Facilities, Inc.
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final notice.
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SUMMARY: This final notice announces the approval of an application
from the American Association for Accreditation of Ambulatory Surgery
Facilities, Inc., (AAAASF) for continued recognition as a national
accrediting organization for ambulatory surgical centers (ASCs) that
request participation in the Medicare or
[[Page 68932]]
Medicaid programs. Following an evaluation of the organizational and
programmatic capabilities of AAAASF, we determined that AAAASF's
standards for ASCs meet or exceed the Medicare conditions for coverage.
Therefore, ASCs accredited by AAAASF under the CMS-approved program
will be deemed to have met the conditions for coverage under the
Medicare program.
EFFECTIVE DATE: This final notice is effective November 26, 2004
through November 26, 2009.
FOR FURTHER INFORMATION CONTACT: Milonda Mitchell, (410) 786-3511.
SUPPLEMENTARY INFORMATION:
I. Background
A. Statutory Provisions and Regulations
Under the Medicare program, eligible beneficiaries may receive
covered services in an ambulatory surgical center (ASC), provided that
the ASC meets certain requirements. Section 1832(a)(2)(F)(i) of the
Social Security Act (the Act) authorizes the Secretary to establish
distinct criteria for a facility seeking designation as an ASC. Under
this authority, the Secretary has set forth in regulations minimum
requirements that an ASC must meet to participate in Medicare. The
regulations at 42 CFR part 416 (Ambulatory Surgical Services) specify
the conditions under which Medicare makes payments for covered services
provided by an ASC. Applicable regulations concerning provider
agreements are at part 489 (Provider Agreements and Supplier Approval)
and those pertaining to facility survey and certification are at part
488 (Survey Certification and Enforcement Procedures), subparts A
(General Provisions) and B (Special Requirements).
B. Verifying Medicare Conditions for Coverage (CfC)
For an ASC to enter into a provider agreement, a State survey
agency must certify that the ASC is in compliance with the conditions
or standards set forth in part 416 of our regulations. Then, the ASC is
subject to ongoing review by a State survey agency to determine whether
it continues to meet the Medicare requirements. However, there is an
alternative to State compliance surveys. Accreditation by a CMS-
approved accreditation program can substitute for ongoing State review.
Section 1865(b)(1) of the Act mandates that provider entities
accredited by CMS-approved accrediting organizations including ASCs are
deemed to be in compliance with Medicare conditions for coverage.
Accreditation by an accreditation organization is voluntary and is not
required of ASCs for participation in the Medicare program.
II. Deeming Application Approval Process
Section 1865(b)(3)(A) of the Act provides a statutory timetable to
ensure that we conduct our review of deeming applications in a timely
manner. The Act provides us with 210 calendar days after the date of
receipt of a complete application to complete our survey activities and
application review process. Within 60 days of receiving a completed
application, we must publish a notice in the Federal Register that
identifies the national accreditation body making the request,
describes the nature of the request, and provides no less than a 30-day
public comment period.
III. Provisions of the Proposed Notice
On July 23, 2004, we published a proposed notice (69 FR 44027) in
the Federal Register that announced the American Association for
Accreditation of Ambulatory Surgery Facilities, Inc.'s (AAAASF's)
request for approval as a deeming organization for ASCs. In that
notice, we detailed our evaluation criteria. Under section 1865(b)(2)
of the Act and regulations at Sec. 488.4, we conducted a review of
AAAASF's application in accordance with the criteria specified by our
regulations, which include, but are not limited to the following:
An onsite administrative review of AAAASF's (1) corporate
policies; (2) financial and human resources available to accomplish the
proposed surveys; (3) procedures for training, monitoring, and
evaluation of its surveyors; (4) ability to investigate and respond
appropriately to complaints against accredited facilities; and (5)
survey review and decision-making process for accreditation.
A comparison of AAAASF's ASC accreditation standards to
our current Medicare conditions for coverage.
A documentation review of AAAASF's survey processes to:
--Determine the composition of the survey team, surveyor
qualifications, and the ability of AAAASF to provide continuing
surveyor training.
--Compare AAAASF's processes to those of State survey agencies,
including survey frequency, and the ability to investigate and respond
appropriately to complaints against accredited facilities.
--Evaluate AAAASF's procedures for monitoring providers or suppliers
found to be out of compliance with AAAASF program requirements. The
monitoring procedures are used only when the AAAASF identifies
noncompliance. If noncompliance is identified through validation
reviews, the survey agency monitors corrections as specified at Sec.
488.7(d).
--Assess AAAASF's ability to report deficiencies to the surveyed
facilities and respond to the facility's plan of correction in a timely
manner.
--Establish AAAASF's ability to provide us with electronic data in
ASCII-comparable code and reports necessary for effective validation
and assessment of AAAASF's survey process.
--Determine the adequacy of staff and other resources.
--Review AAAASF's ability to provide adequate funding for performing
required surveys.
--Confirm AAAASF's policies with respect to whether surveys are
announced or unannounced.
--Obtain AAAASF's agreement to provide us with a copy of the most
current accreditation survey together with any other information
related to the survey that we may require, including corrective action
plans.
In accordance with section 1865(b)(3)(A) of the Act, the proposed
notice also solicited public comments regarding whether AAAASF's
requirements met or exceeded the Medicare conditions for coverage for
ASCs.
We did not receive public comments regarding AAAASF's renewal
application as a national accrediting organization for ASCs.
IV. Provisions of the Final Notice
A. Differences Between AAAASF and Medicare's Conditions and Survey
Requirements
On March 18, 2004, we sent a letter to AAAASF stating that
``AAAASF's new and revised standards meet or exceed the Medicare CfCs
for ASCs and therefore has approved the revisions forwarded to CMS on
March 3, 2004.'' We sent this letter in response to AAAASF's September
2003 submission of new and revised standards. Although, we approved the
new and revised standards on March 18, 2004, AAAASF indicated in a
letter dated June 10, 2004 that ``it will not implement its new
standards until October 1, 2004 and that the approved Medicare
standards will be printed prior to August 1, 2004 and will be sent to
all new applicants after that date.'' Since AAAASF's implementation of
its new and revised standards occurred during the review of its renewal
application, we are including in this final notice AAAASF's
[[Page 68933]]
comments and responses to our review of its crosswalk ``Comparison of
New AAAASF Standards and CMS Standards.'' The purpose of this review
was to ensure that AAAASF's standards met or exceeded the Medicare CfCs
for ASCs. The review yielded the following:
In order to meet the requirements of Sec. 416.41, AAAASF
added to its standard that the governing body is legally responsible
for the safe and effective operation of the ASCs.
We requested AAAASF to clarify its standard AAAASF number
4.020.11.0, regarding its criteria for patient discharge. In addition,
we recommended that AAAASF strike its reference to Post Anesthesia Care
Unit (PACU) and insert ASC. AAAASF responded and revised its standards
by requiring the physician to examine the patient immediately before
discharge from the ASC. Lastly, AAAASF adopted our recommendation and
removed PACU from its standards and inserted ASC.
In order to meet the requirements of Sec. 416.42(c), we
recommended that AAAASF revise its standard, AAAASF standard
8.001.08.0, by requiring the ASCs to provide not only the patient's
legally responsible representative with post-operative instructions
before discharge, but also the actual patient himself or herself with
post-operative instructions before discharge. AAAASF adopted our
recommendation by revising its standard, which now requires adequate
written post-operative instructions (including procedures in emergency
situations) to be given to the patient and, if applicable, the adult
responsible for the patient's care before discharge.
AAAASF standard 10.002.01.0 indicated that the facility
must display ``a professional look.'' We requested that AAAASF provide
a definition/clarification of ``a professional look'' to ensure that
its standard was in accordance with Sec. 416.44. As referenced in
Comparison of New AAAASF Standards and CMS Standards, AAAASF defines a
professional look as ``the facility being properly constructed,
equipped, and maintained to protect the health and safety of
patients.''
In order to meet the requirements of Sec. 416.44(a)(2),
we recommended that AAAASF revise its standard 3.032.02.0, by requiring
the ASC to have a separate recovery and waiting area. AAAASF revised
its standard by requiring ASCs' recovery rooms in its Medicare ASCs to
be distinctly separate and segregated from the waiting area.
We asked AAAASF to revise its standard 9.002.00.1, to
comply with Sec. 416.44(c)(1), by requiring its operating rooms (ORs)
to have an emergency call system present in the OR. AAAASF revised its
standards accordingly.
To comply with Sec. 416.44(c)(4), AAAASF revised its
standard 9.002.00.4, by requiring its facilities to use standard
cardiac defibrillators versus an automated external defibrillators.
We asked AAAASF to revise its standard 9.002.00.9, which
did not state that emergency medication must be readily available in
the OR. The AAAASF standard failed to meet the requirements set forth
in Sec. 416.44(c)(9). AAAASF adopted our recommendation.
AAAASF standard 7.004.09.0 failed to meet our standard
Sec. 416.44(d), by not specifying who was responsible for the use of
cardiopulmonary resuscitation equipment in the ASC. AAAASF revised its
standard by requiring a physician, Certified Registered Nurse
Anesthetist (CRNA) or registered nurse (RN) with Advanced Cardiac Life
Support certification or who is otherwise qualified in resuscitation to
be immediately available in the facility until all patients have been
discharged from the ASC.
AAAASF standard 11.000.05.4 failed to reference granting
privileges in accordance with recommendations from qualified medical
personnel, as referenced at Sec. 416.45(a). AAAASF revised its
standard accordingly.
We requested that AAAASF revise its standard 11.000.01.2,
which failed to state that medical staff would be accountable to the
governing body. AAAASF revised it standard in accordance with our
regulations at Sec. 416.45.
AAAASF standard 4.001.01 did not require medical records
to be complete and comprehensive in accordance with Sec. 416.47.
AAAASF revised its standard by requiring medical records to be
accurate, legible, documented, complete, comprehensive, and filed in a
timely manner to ensure adequate patient care.
In order to meet the requirements of Sec. 416.47(b)(4),
we recommended that AAAASF insert the phrase ``except those exempted by
the governing body'', in its standard 4.020.05.0. AAAASF adopted our
recommendation. The standard now is identical to Sec. 416.74(b)(4).
In order to meet the requirements of Sec. 416.47(b)(5),
we recommended that AAAASF revise its standard 4.003.01.3, by requiring
the medical record to include documentation of patient drug reactions.
AAAASF adopted our recommendation.
In accordance with Sec. 416.47(b)(8), AAAASF revised its
standard 8.000.04.0, to require the physician to include the discharge
diagnosis in the patient's medical record.
In accordance with Sec. 416.48(a), AAAASF revised its
standard 8.001.06.0, to require a physician or RN to administer drugs
to patients.
In addition to conducting a review of AAAASF's standards, we
reviewed the materials contained in ``AAAASF Medicare Resource Guide,''
``AAAASF's Policy and Procedures Manual,'' and AAAASF's ``Introductory
Letter and Informational Packet.'' We compared this information with
our State and Regional Operations Manual. This review yielded the
following:
We asked AAAASF to clarify the name of its Medicare
Program for ASCs, as the organization used the title ``Medicare
Accreditation and Medicare Certification'' interchangeably throughout
its application materials. AAAASF advised us that the name of its
program is ``AAAASF Medicare Accreditation.'' This program accredits
Class B and Class C ASCs.
We requested AAAASF to provide a definition or criteria
for Class B and Class C facilities. According to AAAASF, a Class B
facility performs surgical procedures in the facility under local or
topical anesthesia and/or under intravenous or parenteral sedation,
regional anesthesia, analgesia or dissociative drugs (excluding
Propofol) without the use of endotracheal or laryngeal mask intubation,
or inhalation general anesthesia (including nitrous oxide). In
addition, the Class B facility must meet every standard under AAAASF's
Class A facility requirements. AAAASF defines Class C facilities as
facilities meeting the requirements under Class A and Class B. In
addition, Class C facilities perform surgical procedures with
intravenous Propofol, spinal or epidural anesthesia, endotracheal or
laryngeal mask intubation or inhalation anesthesia (including nitrous
oxide), spinal or epidural, which is administered by an
anesthesiologist or a certified registered nurse anesthetist (CRNA).
We requested AAAASF to clarify its accreditation
decisions, as its policies and procedures indicate that, ``Offices can
be approved or not approved for accreditation or they can be placed on
provisional status.'' AAAASF responded that Class B and Class C
facilities are either granted or denied Medicare Accreditation. These
facilities are required to fully comply with AAAASF's Medicare
standards and are prohibited from receiving provisional status.
We requested AAAASF to provide clarification regarding its
accreditation
[[Page 68934]]
cycle and its self-evaluation process. AAAASF responded that its
Medicare accreditation is effective for 3 years (assuming that the
facility remains in compliance with all AAAASF requirements for
continued Medicare accreditation, which includes completion of a second
and third year self-evaluation). The second and third year self-
evaluation survey is conducted by the Facility Director and/or
Registered Nurse (OR manager) annually to ensure continued compliance
with all AAAASF requirements. AAAASF processes the evaluation and the
facility is notified of any deficiencies. If the facility has any
deficiencies, it is required to correct them within 30 days. AAAASF
performs an onsite Medicare inspection at every consecutive 3-year
cycle.
We asked AAAASF to state who is responsible for performing
the Life Safety Code (LSC) survey for its Medicare ASCs. It responded
that it has contracted with Fire and Life Safety Concepts, L.L.C. to
conduct its unannounced LSC surveys. In addition, AAAASF clarified that
it is not requiring its Medicare ASCs to obtain their own LSC
inspections from a state fire marshal or hired qualified inspector to
qualify for Medicare accreditation.
AAAASF submitted documentation stating that ``The Life
Safety Code inspection is only performed during re-inspection if we
require compliance with a new version of the NFPA Life Safety Code.''
We requested AAAASF to revise this statement, because a LSC survey is
always required during re-accreditation by a deemed accreditation
organization. In addition, we requested AAAASF to require its
facilities to comply with the 2000 edition of the LSC. AAAASF responded
that it will require its Medicare ASCs to obtain LSC surveys at the
time of initial application, application renewal, or in instances which
warrant a complaint survey involving physical environment. AAAASF
provided us with copies of documentation that it sent to its Medicare
ASCs, dated August 25, 2003, advising its facilities that effective
September 11, 2003, all AAAASF Medicare approved ASCs are required to
meet the NFPA 2000 LSC.
We requested AAAASF to develop a comprehensive performance
evaluation program for its Medicare inspectors. AAAASF responded by
implementing a Medicare Inspector Examination Process. At the
conclusion of each Medicare Inspector Training Workshop, an examination
will be administered to assess the inspectors' knowledge and
application of AAAASF's Medicare standards. In addition, we requested
that the AAAASF inspectors accompany a field preceptor for an onsite
Medicare facility inspection as part of the inspector training process.
The field preceptor would complete a competency evaluation to assess
the inspector's knowledge of AAAASF's survey process. Lastly, AAAASF
now requires all of its Medicare ASCs to complete a facility evaluation
form. It is a questionnaire completed by the surveyed facility and is
designed to evaluate the inspector's skills and knowledge as it relates
to the application of AAAASF standards, the inspection process, and
Medicare requirements. AAAASF states that these tools will facilitate
the proper evaluation of its Medicare inspectors' ability to apply
AAAASF standards and survey processes, and will allow AAAASF to
identify training needs for its inspectors.
We asked AAAASF to develop policies and procedures for
monitoring complaints in its Medicare ASCs. AAAASF has a toll-free
hotline that patients, patient family members, or guardians may use to
advise AAAASF of any complaints they may have regarding its Medicare
ASCs. Each Medicare ASC is required to post AAAASF complaint
certificate in its facility. This certificate provides the contact
information individuals need to advise AAAASF of any comments or
questions regarding services provided at the facility. The AAAASF
Investigative Committee reviews all complaints. AAAASF's complaint
categories are ``patient death,'' ``patient safety,'' and ``clinical
practices.'' AAAASF's complaint surveys are always unannounced. The
AAAASF Medicare survey team is responsible for conducting the complaint
surveys in accordance with AAAASF's Medicare standards and with
specific direction from the Investigative Committee chair. The survey
team must investigate complaints involving patient death no later than
20 days after notifying the AAAASF office of the death. This allows the
facility 10 days to respond to the request for information and allows
AAAASF a maximum of 10 days to schedule the mandatory unannounced
inspection. However, when investigating complaints involving patient
safety or clinical practices, the survey team must complete its survey
within 30 days after receipt of the initial complaint. This allows the
facility 10 days to respond to the request for information and allows
AAAASF a maximum of 20 days to schedule the mandatory unannounced
inspection. The Investigative Committee Chair is responsible for
advising the complainant of the result of AAAASF's investigation. The
investigated facility will receive an outcome letter and a written
investigation report. When applicable, the outcome letter will identify
possible follow-up action (for instance, probation, suspension, or
revocation of Medicare accreditation, follow-up visit, plan of
correction, or no further action). Lastly, the outcome letter advises
the facility of its rights to request a hearing in response to AAAASF's
recommendations.
We asked AAAASF to present documentation regarding its
retention of facility files. AAAASF responded by submitting its
policies and procedures for Record Retention and Maintenance. The
policies and procedures state that facility records are maintained in
both hard copy and database format. The hard copy file includes initial
accreditation application records, surgeon credentials, Medicare
accreditation onsite evaluations/outcomes and correspondence. AAAASF
indicated that it purges its records periodically, however, and
maintains the last 3 years' records for the facility including current
credentials, correspondence, and evaluations.
We asked AAAASF to clarify its procedures for scheduling
Medicare accreditation surveys. AAAASF responded by submitting its
policy, ``Procedure for Securing a Medicare Inspector.''
B. Term of Approval
Based on the review and observations described in section III of
this final notice, we determined that AAAASF's requirements for ASCs
meet or exceed our requirements. Therefore, we recognize AAAASF as a
national accreditation organization for ASCs that request participation
in the Medicare program, effective November 26, 2004 through November
26, 2009.
V. Regulatory Impact Statement
We have examined the impact of this notice as required by Executive
Order 12866 (September 1993, Regulatory Planning and Review), the
Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354),
section 1102(b) of the Social Security Act, the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential
[[Page 68935]]
economic, environmental, public health and safety effects; distributive
impacts; and equity). A regulatory impact analysis (RIA) must be
prepared for major rules with economically significant effects ($100
million or more in any 1 year). This final notice recognizes AAAASF as
a national accreditation organization for ASCs that request
participation in the Medicare and Medicaid programs. There are neither
significant costs nor savings for the program and administrative
budgets of Medicare. Therefore, this notice is not a major rule as
defined in Title 5, United States Code, section 804(2) and is not an
economically significant rule under Executive Order 12866.
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and Government agencies.
Most hospitals and most other providers and suppliers are small
entities, either by nonprofit status or by having revenues of $6
million to $29 million in any 1 year. Individuals and States are not
included in the definition of a small entity. For purposes of the RFA,
States and individuals are not considered small entities. We are not
preparing an analysis for the RFA because we have determined that this
notice will not have a significant economic impact on a substantial
number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 100 beds. We are not preparing an
analysis for section 1102(b) of the Act because we have determined that
this notice will not have a significant impact on the operations of a
substantial number of small rural hospitals.
In an effort to better assure the health, safety, and services of
beneficiaries in ASCs already certified as well as provide relief to
State budgets in this time of tight fiscal restraints, we deem ASCs
accredited by AAAASF as meeting its Medicare requirements. Thus, we
continue our focus on assuring the health and safety of services by
providers and suppliers already certified for participation in a cost-
effective manner.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule that may result in expenditure in any 1 year by State,
local, or tribal governments, in the aggregate, or by the private
sector, of $110 million. This notice will have no consequential effect
on the governments mentioned or on the private sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has federalism
implications. Since this notice does not impose any costs on State or
local governments, the requirements of E.O. 13132 are not applicable.
In accordance with the provisions of Executive Order 12866, this
notice was not reviewed by the Office of Management and Budget.
Authority: Section 1865 of the Social Security Act (42 U.S.C.
1395bb)
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program; No. 93.773 Medicare--Hospital Insurance Program;
and No. 93.774, Medicare--Supplemental Medical Insurance Program)
Dated: October 22, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 04-25830 Filed 11-19-04; 8:45 am]
BILLING CODE 4120-01-P